Policy: Protas contributes to major clinical trial milestones
Rounding out a successful 2024, Protas has played a significant role in shaping three major policy efforts, heralding promising change in how large trials are designed and delivered in the UK and worldwide.
As part of Protas’ mission to tackle the global burden of common diseases through smarter clinical trials, we work with some of the leading organisations in healthcare to effect change at scale.
In a year that has been hugely successful for our work designing and delivering clinical trials, and finding innovative ways of using data and technology, we also round out 2024 with several successes in shaping national and international policy.
Clinical trial reform tabled at UK parliament
Last week saw a major landmark for clinical trials in the UK as new legislation was laid in parliament that will change the regulatory framework for clinical trials.
The largest overhaul in 20 years, the legislation aims to make the sector more efficient and streamline the process of bringing new treatments to the NHS.
For several years, Protas Chief Executive Prof Sir Martin Landray has been part of an advisory group for the Medicines and Healthcare products Regulatory Agency (MHRA), which is proposing the reform.
It aims to “protect the safe development of pioneering new treatments for the benefit of patients and the NHS” and set the UK as “one of the best places in the world to conduct research”.
Sir Martin said: “Clinical trials are the foundation of evidence-based medicines. They are the way we get to understand whether the hopes of a promising new treatment turn into real benefits for patients.
“If we are to see those innovations have a real impact on patients and public health, we need an efficient way to thoroughly test their efficacy and safety through clinical trials.
“New legislation that shortens the timelines for clinical trials, reduces the burden for patients, and increases the quality of the evidence they generate are key to putting the UK at the forefront of advances in medical care.”
The proposal aligns with our mission at Protas to dramatically decrease the complexity, timelines and cost of large clinical trials, while enabling them to deliver higher-quality evidence that can inform clinical decision making.
Collaboration with WHO on clinical trial best practice
In September, the World Health Organization (WHO) issued new guidance for best practices for clinical trials, based on the work of the Good Clinical Trials Collaborative.
Established in 2019 with funding from Wellcome and the Bill & Melinda Gates Foundation, and coordinated by Protas, the Collaborative has developed guidance that ultimately identifies five underpinning principles of good randomised controlled trials:
Good clinical trials:
- Are designed to produce scientifically sound answers to relevant questions
- Respect the rights and well-being of participants
- Are collaborative and transparent
- Are designed to be feasible for their context
- Manage trial quality effectively and efficiently
The WHO’s new guidance emphasises and builds on these same principles.
This December, 10,000 people registered for a webinar hosted by The Global Health Network to hear WHO’s Chief Scientist, Jeremy Farrar, and Senior Advisor, Research and Development, Vasee Moorthy, discuss the importance of these new guidelines to the future of clinical research and healthcare around the world.
Building a 10-Year Health Plan with the NHS
The UK government is developing a new 10-Year Health Plan to deliver on its ambition to build an “NHS fit for the future”, through three key transformations – hospital to community, analogue to digital, sickness to prevention. The work builds on Lord Darzi’s independent investigation into the NHS, which we welcomed.
Sir Martin was recently appointed to be a member of the Research, Life Sciences and Innovation working group, which is tasked with considering how the NHS can identify and capitalise on technologies such as genomics, artificial intelligence and novel drug therapeutics.
The group will also consider how the NHS currently supports research and innovation and what can be done to increase the speed and scale of adoption of effective new innovations.
Generating reliable information about the effects of potential treatments for common disease through clinical trials will be key to ensure that the necessary transformations have the desired impact on high-quality, equitable healthcare.
2024 at Protas
These developments conclude another successful year for Protas.
We continue to partner with some of the most influential organisations in healthcare, this year building towards our first major trial and consulting on more than a dozen protocols for large and small pharmaceutical companies.
Our team grew by over 20% to support our work in transforming clinical trials, with a diversity of background and breadth of expertise to ensure that our work is reflective of the diversity of patients who will benefit from them.
We also launched Cantata, our unified clinical trials management platform, with Oxford Population Health and Boehringer-Ingelheim being the first users of the platform for the EASi-KIDNEY trial – the world’s largest trial into chronic kidney disease.
To find out more about how we could work together, contact us here.